MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Low Blood Pressure/ Hypotension (1914); Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 03/23/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8598a, serial#: (b)(4), implanted: (b)(6) 2018, product type: catheter.Product id: 85 96sc, serial# (b)(4), implanted: (b)(6) 2018, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a clinical study regarding a patient with an implantable pump for non-malignant pain.Per the session report from 2020-feb-06, the pump administered the following medications as of (b)(6) 2019: fentanyl (concentration: 2000 mcg, dose rate: 900.09156 mcg/day), bupivacaine (concentration: 20 mg, dose rate: 9.00092 mg/day), and morphine (concentration: 5.8 mg, dose rate: 2.61027 mg/day).It was reported that the patient indicated that over the past 6 weeks, a gradual increase in pain had occurred.The date (b)(6) 2020 is considered an approximate date of event (specific month and year known only).It was further noted that the patient had been in and out of the hospital due to diarrhea, hypotension and abdominal pain.The patient didn¿t feel boluses and possible withdrawals was further noted.The programming date from the most recent refill prior to event occurred on (b)(6) 2020.The clinical diagnosis was increase in pain.The date of test was (b)(6) 2020.A catheter access port (cap) contrast study on (b)(6) 2020 revealed normal catheter function.Actions taken to resolve the issue included reprogramming and an increase in fentanyl occurred on (b)(6) 2020.The event resulted in-patient hospitalization.Regarding etiology, it was indicated that the relationship of the event to the device or therapy was possibly related and it was indicated that there was no change in drug.The event was noted as not having been related to the implant procedure.The event was ongoing.No further patient complications have been reported as a result of this event.

Event Description

Additional information was received from an hcp via a clinical study on 2020-aug-08.It was reported that on (b)(6) 2020, the patient reported their pain was well controlled with the pump therapy.The event was resolved without sequelae on that date.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 10026715
• MDR Text Key: 190337419
• Report Number: 3004209178-2020-08126
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/04/2020
• Initial Date FDA Received: 05/05/2020
• Supplement Dates Manufacturer Received: 08/08/2020
• Supplement Dates FDA Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 63 YR
• Patient Weight: 93